Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

November 1, 2023 updated by: Maya Suresh, The University of Texas Health Science Center, Houston
The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • elective or non-elective cesarean delivery on prior day
  • pain scores >5/10

Exclusion Criteria:

  • BMI >40
  • obstructive sleep apnea
  • drug abuse
  • chronic pain
  • chronic opioid use
  • abdominal surgeries other than cesarean delivery
  • contraindications to neuraxial or regional anesthesia
  • received general anesthesia or did not receive neuraxial morphine for cesarean delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham Control
20 milliliters (mL) 0.9% saline on each side
Drug: Saline
0.9% saline on each side
Experimental: Quadratus Lumborum Block
20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side
Drug: Bupivacaine
0.25% bupivacaine (50mg) on each side
Drug: Dexamethasone
3mg preservative-free dexamethasone on each side

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total opioid consumption
Time Frame: 48 hours after intervention
48 hours after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Amount of opioids used
Time Frame: at the time of intervention (one day following cesarean delivery)
at the time of intervention (one day following cesarean delivery)
Amount of opioids used
Time Frame: 6 hours after intervention
6 hours after intervention
Amount of opioids used
Time Frame: 12 hours after intervention
12 hours after intervention
Amount of opioids used
Time Frame: 24 hours after intervention
24 hours after intervention
Amount of opioids used
Time Frame: 48 hours after intervention
48 hours after intervention
Time from quadratus lumborum block until first opioid request
Time Frame: from time of intervention until time of first opioid request (up to 48 hours)
from time of intervention until time of first opioid request (up to 48 hours)
Pain as measured by an 11-point verbal pain score (at rest)
Time Frame: at the time of intervention (one day following cesarean delivery)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
at the time of intervention (one day following cesarean delivery)
Pain as measured by an 11-point verbal pain score (with movement)
Time Frame: at the time of intervention (one day following cesarean delivery)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
at the time of intervention (one day following cesarean delivery)
Pain as measured by an 11-point verbal pain score (at rest)
Time Frame: 6 hours after intervention
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
6 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
Time Frame: 6 hours after intervention
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
6 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)
Time Frame: 12 hours after intervention
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
12 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
Time Frame: 12 hours after intervention
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
12 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)
Time Frame: 24 hours after intervention
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
24 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
Time Frame: 24 hours after intervention
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
24 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)
Time Frame: 48 hours after intervention
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
48 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
Time Frame: 48 hours after intervention
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
48 hours after intervention
Nausea as measured by a 3-point scale
Time Frame: at the time of intervention (one day following cesarean delivery)
This is measured categorically as none, mild, or moderate-severe.
at the time of intervention (one day following cesarean delivery)
Nausea as measured by a 3-point scale
Time Frame: 6 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
6 hours after intervention
Nausea as measured by a 3-point scale
Time Frame: 12 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
12 hours after intervention
Nausea, pruritus and sedation as measured by a 3-point scale
Time Frame: 24 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
24 hours after intervention
Nausea as measured by a 3-point scale
Time Frame: 48 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
48 hours after intervention
Pruritus as measured by a 3-point scale
Time Frame: at the time of intervention (one day following cesarean delivery)
This is measured categorically as none, mild, or moderate-severe.
at the time of intervention (one day following cesarean delivery)
Pruritus as measured by a 3-point scale
Time Frame: 6 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
6 hours after intervention
Pruritus as measured by a 3-point scale
Time Frame: 12 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
12 hours after intervention
Pruritus as measured by a 3-point scale
Time Frame: 24 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
24 hours after intervention
Pruritus as measured by a 3-point scale
Time Frame: 48 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
48 hours after intervention
Sedation as measured by a 3-point scale
Time Frame: at the time of intervention (one day following cesarean delivery)
This is measured categorically as none, mild, or moderate-severe.
at the time of intervention (one day following cesarean delivery)
Sedation as measured by a 3-point scale
Time Frame: 6 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
6 hours after intervention
Sedation as measured by a 3-point scale
Time Frame: 12 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
12 hours after intervention
Sedation as measured by a 3-point scale
Time Frame: 24 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
24 hours after intervention
Sedation as measured by a 3-point scale
Time Frame: 48 hours after intervention
This is measured categorically as none, mild, or moderate-severe.
48 hours after intervention
Patient satisfaction as measured by the 5-point Likert scale
Time Frame: 48 hours after intervention
The 5-point scale ranges from extremely satisfied to not satisfied.
48 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linden Lee, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-20-0124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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